Indication & Safety Information for LUNESTA® (eszopiclone)
WARNING: COMPLEX SLEEP BEHAVIORS
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA®. Some of these events may result in serious injuries, including death. Discontinue LUNESTA® immediately if a patient experiences a complex sleep behavior.
LUNESTA® acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep. Do not take LUNESTA® if you are allergic to anything in it. LUNESTA® should not be taken together with alcohol. Until you know how you will react to LUNESTA®, you should not drive or operate machinery. Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. Walking, eating, driving or engaging in other activities while asleep without remembering it the next day have been reported. Other abnormal behaviors include aggressiveness, agitation, hallucinations and confusion. In depressed patients, worsening of depression including risk of suicide may occur. These risks may increase if you drink alcohol. Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal. Call your doctor if you experience these or any effects or reactions that concern you. LUNESTA®, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness and dizziness.
INDICATIONS AND USAGE
LUNESTA® is indicated for the treatment of insomnia. LUNESTA® has been shown to decrease sleep latency and improve sleep maintenance.
CONTRAINDICATIONS
- Patients who have experienced complex sleep behaviors after taking LUNESTA®
- Known hypersensitivity to eszopiclone
IMPORTANT SAFETY INFORMATION AND INDICATIONS
WARNING: COMPLEX SLEEP BEHAVIORS
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA®. Some of these events may result in serious injuries, including death. Discontinue LUNESTA® immediately if a patient experiences a complex sleep behavior. See full warnings and precautions
Indication & Safety Information for LUNESTA® (eszopiclone)
LUNESTA® acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep. Do not take LUNESTA® if you are allergic to anything in it. LUNESTA® should not be taken together with alcohol. Until you know how you will react to LUNESTA®, you should not drive or operate machinery. Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. Walking, eating, driving or engaging in other activities while asleep without remembering it the next day have been reported. Other abnormal behaviors include aggressiveness, agitation, hallucinations and confusion. In depressed patients, worsening of depression including risk of suicide may occur. These risks may increase if you drink alcohol. Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal. Call your doctor if you experience these or any effects or reactions that concern you. LUNESTA®, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness and dizziness.
INDICATIONS AND USAGE
LUNESTA® is indicated for the treatment of insomnia. LUNESTA® has been shown to decrease sleep latency and improve sleep maintenance.
CONTRAINDICATIONS
- Patients who have experienced complex sleep behaviors after taking LUNESTA®
- Known hypersensitivity to eszopiclone
WARNINGS AND PRECAUTIONS
Complex Sleep Behaviors
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of LUNESTA®. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with LUNESTA® alone at recommended dosages, with or without the concomitant use of alcohol or other CNS depressants. Discontinue LUNESTA® immediately if a patient experiences a complex sleep behavior.
CNS Depressant Effects and Next-Day Impairment
LUNESTA® is a CNS depressant and can impair daytime function in some patients at the higher doses (2 mg or 3 mg), even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of symptoms (or even with subjective improvement), and impairment may not be reliably detected by ordinary clinical exam (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of LUNESTA® may develop, patients using 3 mg LUNESTA® should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.
Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of LUNESTA® and concomitant CNS depressants should be considered.
The use of LUNESTA® with other sedative-hypnotics at bedtime or the middle of the night is not recommended.
The risk of next-day psychomotor impairment is increased if LUNESTA® is taken with less than a full night of sleep remaining (7- to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants; or co-administered with other drugs that increase the blood levels of eszopiclone.
Because Lunesta can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.
Need to Evaluate for Comorbid Diagnoses
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including LUNESTA®. Because some of the important adverse effects of LUNESTA® appear to be dose related, it is important to use the lowest possible effective dose, especially in the elderly.
Severe Anaphylactic and Anaphylactoid Reactions
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including LUNESTA®. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with LUNESTA® should not be rechallenged with the drug.
Abnormal Thinking and Behavioral Changes
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Withdrawal Effects
Following rapid dose decrease or abrupt discontinuation of the use of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs.
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
THIS IS NOT THE FULL SAFETY INFORMATION FOR LUNESTA®. PLEASE VIEW FULL PRESCRIBING INFORMATION BELOW:
View Full LUNESTA® Prescribing Information (Waylis 1mg, 2mg) | View Full LUNESTA® Prescribing Information (Sunovion 1mg, 2mg, 3mg)